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Safety and Efficacy of Atherectomy on VasculaR Functions

NCT04092972 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-25

No results posted yet for this study

Summary

Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.

Conditions

  • Peripheral Arterial Disease
  • Claudication, Intermittent

Interventions

OTHER

Atherectomy

Straub Rotarex S atherectomy and drug-coated balloon DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA).

OTHER

POBA and DCB

Standard predilation (POBA) and DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA).

Sponsors & Collaborators

  • Straub Medical AG

    collaborator INDUSTRY

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Christos Rammos · Universität Duisburg-Essen

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-07-28
Completion
2021-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092972 on ClinicalTrials.gov